Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

NCT ID: NCT01107171

Last Updated: 2010-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-12-31

Brief Summary

Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic effects on the experimental rats and no obvious toxicity was found.This is a randomized, doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore the optimal dosage of Tang-min-ling pills.

Detailed Description

Two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into 3 groups, and were given high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、syndrome、symptoms、body mass index (BMI)、waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

Tang-min Lin pills analogue

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tang-min-Ling pills analogue 6g,tid,po

Tang-min-ling pills high dosage

Tang-min-ling pills, high dosage, 12g, tid po

Group Type: EXPERIMENTAL

Tang-min-ling pills high dosage

Intervention Type: DRUG

high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Tang-min-ling pills low dosage

low dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Group Type: EXPERIMENTAL

Tang-min-ling pills low dosage

Intervention Type: DRUG

low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Interventions

Tang-min-ling pills low dosage

low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Intervention Type: DRUG

Tang-min-ling pills high dosage

high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Intervention Type: DRUG

Placebo

Tang-min-Ling pills analogue 6g,tid,po

Intervention Type: DRUG

Other Intervention Names

Tang min lin pill; Tang min lin pills; Tang-min-Ling pills analogue

Eligibility Criteria

Inclusion Criteria

1. Patients with primary type 2 diabetes mellitus

2. BMI ≥ 24 kg•m-2

3. 30-70 years old

4. HbA1c≥7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L

5. Informed consent has been signed

6. stagnated heat of liver and stomach syndrome according to TCM syndrome differentiation

Exclusion Criteria

1. The patients accepted diabetic treatment for more than a month continuously

2. The patients were treated by drugs in 3 week before they were given test drugs

3. Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month

4. The contractive pressure >160 mmHg or diastolic pressure >100 mmHg

5. Pregnant, preparing for pregnancy or breast-feeding women

6. Mental patients

7. The patients who have serious heart, lung, liver, kidney and brain or other primary complications

8. Allergic persons

9. The patients who are attending other clinical trial

10. The patients who have serious diabetic complications

11. The patients who ever attended this clinical trial

12. Alcohol and / or psychoactive substances, drug abuse and dependency

13. The person maybe loss for some reason such as work or life condition according to the investigator's judgement

14. The lipid-lowering or antihypertensive drug dosage and category which the patients are taking couldn't be kept stable

15. The patients who are eating some drugs or health food which can affect the body weight

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tasly Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Principal Investigators

Xiaolin Tong, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Guang Anmen Hospital of China Academy of Chinese Medical Sciences

Locations

The Affiliated Hospital to Changchun University of Chinese Medicine

Changchun, , China

Jilin Hospital of Integrated Traditional and Western Medicine

Changchun, , China

Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine

Shanghai, , China

The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine

Shenyang, , China

The Second Affiliated Hospital to Liaoning University of TCM

Shenyang, , China

First Teaching Hospital of Tianjin University of TCM

Tianjin, , China

Countries

China

Other Identifiers

2008002P2A02

Identifier Type: -

Identifier Source: org_study_id